Qualified Person for Pharmacovigilance (EU QPPV) – Leinster, Ireland | Flexible/Remote Work
Job Summary:
Thornshaw Recruitment, on behalf of a leading life sciences consultancy, is seeking an experienced Qualified Person for Pharmacovigilance (EU QPPV) to ensure full regulatory compliance across the UK and EEA. This high-responsibility position requires a deep understanding of pharmacovigilance legislation and leadership in overseeing PV systems and regulatory communications. The company offers truly flexible working, empowering team members to work when and where they choose.
Key Responsibilities:
Serve as EEA QPPV under EU Directive 2001/83/EC and other applicable regulations
Maintain continuous safety profile oversight and identify emerging safety concerns
Ensure compliance in safety submissions and PV system management
Act as 24/7 point-of-contact with the EMA and other competent authorities
Oversee Risk Management Plans (RMPs), PSMFs, and Post-Authorisation Safety Studies (PASS)
Support internal audits and regulatory inspections with readiness and training
Contribute to CAPAs and safety quality systems as required
Lead and influence cross-functional teams and stakeholders on PV matters
Required Skills & Qualifications:
Life Sciences degree (mandatory)
Minimum 7 years’ experience in the pharmaceutical industry with core PV expertise
In-depth knowledge of:
Directive 2001/83/EC, Regulations EC 726/2004 & 520/2012
Good Pharmacovigilance Practices (GVP) guidelines
Human Medicines Regulations 2012, MHRA post-Brexit guidance
Medical Device Regulations (Statutory Instruments)
Documented experience across all PV functions necessary for QPPV status
Demonstrated participation in regulatory inspections and audits
Strong leadership, problem-solving, and cross-functional communication skills
Must be based and operating in Ireland
Perks & Benefits:
Fully flexible working hours and location – Remote/Hybrid/On-site options
High-impact leadership role within a supportive and modern work culture
Join a growing, agile consultancy committed to regulatory excellence
Opportunities for further professional growth and compliance leadership
Autonomy from Day 1 and supportive team dynamics
Company Description:
Thornshaw Recruitment, a division of CPL Group, specializes in connecting top talent with life sciences leaders across the pharmaceutical, biotechnology, and healthcare sectors. Their client, a progressive life sciences consultancy, supports global PV compliance and offers a healthy work-life balance driven by flexibility and empowerment.
Work Mode: Remote / Flexible / Leinster-based
Call to Action:
Are you ready to lead pharmacovigilance strategy in a flexible, autonomous role? If you're a seasoned QPPV ready to make a regulatory impact across Europe, apply now or send your CV to tdunne@thornshaw.com and take the next step in your drug safety leadership journey.
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